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Groundbreaking MUSC Trial For Brain Cancer Patients

MUSC announced the opening of patient enrollment in a multi-center clinical trial for Cotara®, an investigational drug that acts like a biological guided missile for the treatment of glioblastoma multiforme (GBM), which is a particularly deadly form of brain cancer. The trials, sponsored by Peregrine Pharmaceuticals Inc., are also underway at other clinical sites including the University of Pennsylvania.

MUSC is the only center in South Carolina capable of providing this potentially groundbreaking treatment. "Based on the scientific rationale for Cotara, coupled with some positive preliminary indications from previous trials, we believe it is important to study this radiopharmaceutical approach as a new option for this deadly disease," said Sunil Patel, M.D. Department of Neurosciences clinical chairman and lead for the MUSC trial. "According to the New England Journal of Medicine (11/10/06), the vast majority of glioblastoma multiforme patients die soon after receiving the diagnosis, so this trial is exceptionally important." Patel explained that MUSC was a part of earlier clinical trials of Cotara, and that Cotara has been granted orphan drug status and fast track designation by the U.S. Food and Drug Administration for treatment of GBM.

One Charleston resident with GBM was treated with Cotara and has survived more than six years since his treatment began, while most GBM patients do not live another year from diagnosis. While this patient has recently suffered a recurrence of his disease, researchers are encouraged by his long survival and are eager to test whether newer methods of drug administration might produce similar or even better results in patients today.

According to Patel, brain tumors are particularly difficult to treat because "fingers" of malignant cells spread out from the tumor and take root deep in the surrounding tissue, making it difficult to remove them without damaging healthy brain cells. Cotara is a monoclonal antibody that homes in directly on the DNA of cancer cells and carries a radioactive isotope to the tumor that literally destroys the cancer cells from the inside out. This approach targets the cancer cells while sparing healthy tissue in the brain and reducing side effects.

About Cotara®

Cotara is an experimental new treatment for brain cancer being developed by Peregrine Pharmaceuticals. In previous clinical studies, Cotara has demonstrated encouraging results in patients with advanced brain cancer. One study demonstrated a 58% increase in median survival time in a group of patients suffering from late stage glioblastoma multiforme who were treated with Cotara. This was considered a promising development in this serious and deadly disease. Cotara is currently being studied in clinical trials in glioblastoma patients at a number of leading brain cancer centers in the U.S. and India. Cotara has been granted orphan drug status and fast track designation for the treatment of glioblastoma multiforme and anaplastic astrocytoma by the U.S. Food and Drug Administration.

About MUSC

Founded in 1824 in Charleston, The Medical University of South Carolina is the oldest medical school in the south. Today, MUSC continues the tradition of excellence in education, research, and patient care. MUSC is home to over 3,000 students and residents, as well as nearly 10,000 employees, including 1,300 faculty members. As the largest non-federal employer in Charleston, the University and its affiliates have collective budgets in excess of $1.3 billion per year. MUSC operates a 600 bed medical center, which includes a nationally recognized Children's Hospital and a leading Institute of Psychiatry.